Cardima Announces Fourth Quarter and Full Year Financial Results.Business Editors & Health/Medical Writers FREMONT Fremont (frē`mŏnt). 1 City (1990 pop. 173,339), Alameda co., W Calif., on San Francisco Bay; inc. 1956. Long an agricultural center, with champagne vineyards founded (1870) by Leland Stanford, it still ships fruits and vegetables. , Calif.--(BW HealthWire)--Feb. 20, 2002 Quarterly Highlights Include Market Certification for REVELATION Helix in Europe Europe (y  r`əp), 6th largest continent, c.4,000,000 sq mi (10,360,000 sq km) including adjacent islands (1992 est. pop. 512,000,000). , FDA FDAabbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Acceptance of Two PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy Modules for REVELATION Tx, Strengthened Cash Position through Warrant Redemption Cardima(R), Inc. (Nasdaq SC:CRDM CRDM Control Rod Drive Mechanism CRDM Centre for Rapid Design and Manufacture (Buckinghamshire Chilterns University) CRDM Cumann Rince Dea Mheasa (Irish dancing organisation) ), developer of the REVELATION(TM) Tx and REVELATION(TM) Helix microcatheter systems for the treatment of atrial fibrillation atrial fibrillation Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection. (AF), today reported financial results for the fourth quarter and year ended December December: see month. 31, 2001. Revenues for the fourth quarter of 2001 were $384,000, compared with $731,000 for the fourth quarter of 2000, a decrease of 47%. The operating loss operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. for the fourth quarter of 2001 increased 34% to $3,636,000 from $2,706,000 for the comparable period last year, primarily due to higher sales, general and administrative expenses, and to increased expenses for clinical trials in the U.S. and Europe. The net loss for the fourth quarter of 2001 was $3,617,000, or $0.09 per share, compared with net income of $1,283,000, or $0.06 per share, for the same period in 2000, which included a $4,000,000 gain on the sale of certain patents. "During the fourth quarter of 2001, we reached a major milestone in our goal to bring new, innovative AF products to market by receiving European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community approval for the REVELATION Helix," said Gabriel Vegh, Cardima's chief executive officer. "We believe that Cardima is currently the only company with European Union certification to market catheters to treat AF in both the left and right atria Atria The heart has four chambers. The right and left atria are at the top of the heart and receive returning blood from the veins. The right and left ventricles are at the bottom of the heart and act as the body's main pumps. of the heart. "Additionally in the fourth quarter, we gained U.S. Food and Drug Administration (FDA) acceptance of two of the pre-market Pre-Market Trading done before the regular market opens. Notes: Participation by market makers and ECNs is voluntary, so in pre-market there may be less liquidity than during normal hours of trading. approval (PMA) modules for the REVELATION Tx system, thereby bringing us closer to receiving FDA approval for our lead product," added Mr. Vegh. "We also strengthened our balance sheet during the quarter by $5.1 million through a redemption of warrants." For the year ended December 31, 2001, revenues were $1,861,000, a decrease of 28% from revenues of $2,570,000 for the year ended December 31, 2000, reflecting the Company's stated focus on the clinical trials of its therapeutic products for treating AF. Selling, general and administrative expenses in 2001 increased by $490,000 and research and development expenses increased by $441,000 over 2000 due to regulatory and clinical expenses for the REVELATION Tx and the REVELATION Helix clinical trials. The 2001 operating loss was $13,404,000, compared with $11,714,000 in 2000. The net loss for 2001 was $9,341,000, or $0.30 per share, compared with a net loss of $7,849,000, or $0.38 per share, for 2000. The Company recorded $4,000,000 of other income in both December 2000 and January 2001 as a result of selling certain patents. Interest income in 2001 decreased $107,000 from 2000 as a result of lower interest rates, while interest expense in 2001 decreased $305,000 as a result of reduced debt. Commenting on the 2001 year, Mr. Vegh said, "We are extremely pleased with Cardima's many achievements since our decision in January 2001 to focus the Company's efforts and resources solely on bringing innovative AF products to the market. Among our accomplishments, we made significant progress in bringing the REVELATION Tx system through the FDA approval process; we raised $15.7 million of new equity, which has allowed us to move forward with our quest to gain necessary marketing approvals; and we improved our intellectual property position by adding three new U.S. patents. "In the current year, our goals are to receive FDA approval to market the REVELATION Tx in the U.S., to initiate the FDA approval process for the REVELATION Helix, and to continue introducing the REVELATION Helix system in Europe," added Mr. Vegh. Cardima has scheduled an investor conference call regarding this announcement to be held today, beginning at 4:30 p.m. Eastern Time. To participate in the live call via telephone, please call (800) 540-0559. A telephone replay will be available until 6:30 p.m. Eastern Time February 22, 2002 by dialing (877) 710-5301. Individuals interested in listening to the conference call via the Internet Internet Publicly accessible computer network connecting many smaller networks from around the world. It grew out of a U.S. Defense Department program called ARPANET (Advanced Research Projects Agency Network), established in 1969 with connections between computers at the may do so by visiting the Company's website at www.cardima.com. A replay will be available on the website for 90 days. Cardima, Inc. developed the linear ablation ablation /ab·la·tion/ (-shun) 1. separation or detachment; extirpation; eradication. 2. removal or destruction, especially by cutting. ab·la·tion n. REVELATION Tx system for treating AF. Since AF afflicts an estimated 2.3 million people in the U.S. and approximately 4.5 million people worldwide, the Company believes it is a potential $6 billion market that is poorly served by current treatment alternatives. The REVELATION Tx microcatheter system is a minimally invasive invasive /in·va·sive/ (-siv) 1. having the quality of invasiveness. 2. involving puncture of the skin or insertion of an instrument or foreign material into the body; said of diagnostic techniques. , single-use system for potentially curing AF, and is believed by the Company to be at least two years ahead of other development-stage ablation therapies ablation therapy See Ablation–cardiology. in the approval process. Phase I and II data with the REVELATION Tx microcatheter system demonstrated safety and promising efficacy. The Company is targeting approval for the REVELATION Tx by the end of calendar year 2002. The Company's REVELATION Helix received CE mark approval in December 2001 and has just commenced market launch in the European Union. Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. that involve risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include the Company's ability to raise additional capital, conduct successful clinical trials, obtain regulatory approvals and gain acceptance from the marketplace for its products. Additional risks are set forth in the Company's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2000 filed with the Securities and Exchange Commission on March 22, 2001, and subsequent Form 10-Qs Form 10-Q See 10-Q. issued in 2001. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances CIRCUMSTANCES, evidence. The particulars which accompany a fact. 2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or after the date hereof here·of adv. Of this. hereof Adverb Formal or law of or concerning this Adv. 1. hereof - of or concerning this; "the twigs hereof are physic" , or to reflect the occurrence of unanticipated events.
Cardima, Inc.
Statements of Operations
In thousands, except per share amounts
Three months ended Year ended
December 31, December 31,
2001 2000 2001 2000(a)
(Unaudited) (Unaudited) (Unaudited)
Revenues $384 $731 $1,861 $2,570
Cost of goods sold 849 1,256 3,717 3,667
Gross margin (465) (525) (1,856) (1,097)
Operating expenses:
Research and
development 1,135 785 4,873 4,432
Sales, general and
administrative 2,036 1,396 6,675 6,185
Total operating
expenses 3,171 2,181 11,548 10,617
Operating loss (3,636) (2,706) (13,404) (11,714)
Interest income 30 49 123 230
Interest expense (11) (60) (60) (365)
Other income -- 4,000 4,000 4,000
Net income/loss $(3,617) $1,283 $(9,341) $(7,849)
Net income/(loss) per
share $(0.09) $0.06 $(0.30) $(0.38)
Shares used in
calculating net
income/(loss) per
share 39,045 21,579 31,114 20,818
Selected Balance Sheet Data
In thousands
December 31,
2001 2000(a)
(Unaudited)
Cash, cash equivalents and
short-term investments $7,542 $1,324
Working capital 6,756 653
Total assets 11,818 5,903
Total liabilities 3,061 3,009
Stockholders' equity 8,757 2,894
(a) Derived from audited financial statements
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